Contraceptives

It appears that 9 years after Sidney Wolfe, MD, head of the Public Citizen Health Research Group warned that the drug drospirenone (in Yaz) could cause “serious heart and other health problems such as a change in acid balance of the blood and muscle weakness” the ‘experts’ have not been able to satisfactorily dispel my drospirenone ‘black cloud’ that still hovers. The FDA advisory panel that met on Dec. 8th (Wolfe was excluded from voting due to an “intellectual conflict of interest.”) decided that the benefits of drospirenone-containing contraceptives outweigh the slightly increased risk of blood clots. Even though they are not in 100% agreement after reviewing current studies, the FDA panel voted to keep the ‘new’ pills containing drospirenone on the market. After this lukewarm result, from my point of view, the ball is bounced back into our court with a majority recommendation by the panel that all drospirenone contraceptives should carry improved labels, warning users of the potentially fatal risks of leg and lung blood clots. Ya think? No New Year’s resolution to dig deeper here? Surely we deserve better than this after 9 years and 10,000 lawsuits* on the counter?

If You Already Take a Low Dose Birth Control Pill - you have accepted the well known, ‘risk over benefit scenario ‘ of blood clots. This risk is accepted by the medical profession as being a small one and has been listed on pill packets for over 50 years. However, even a slightly higher risk acknowledged in a new drug can be critical because blood clots can trigger heart attacks, strokes and blockages in lungs or blood vessels. It’s up to you to thoroughly weigh up any benefits of taking a higher risk with a pill containing drosprinenone above one with a different type of synthetic progestin.

  Other Confounding Factors which influence blood clotting risk include:

• smoking
• age over 35
• obesity
• PCOS (polycystic ovary syndrome)
• a family history of heart disease or a clotting disorder

….all of which make it even more urgent that further research on hormone based drugs and the blood clotting factor is pursued.. 

According to the FDA review, 10 in 10,000 women (see list in previous post) will suffer a potentially deadly blood clot as a result of taking a hormonal contraceptive. How else are we at risk of developing a blood clot though?

• about 20 in every 10,000 women who are pregnant or just gave birth develop blood clots
• one in every 4,500 people develops a blood clot after flying (according to the World Health Organization)

Prior to posting this result, I’ve been digging around for ‘inside’ information on these proceedings and include these links for those of you who’d like to know more about the hidden files, withheld information and what else has been going on backstage.

http://news.businessweek.com/article.asp?documentKey=1376-LVQYL56S972I01-7V9D1IMKMU35U8DIJ4NU7MFOEJ

http://dissidentvoice.org/2011/12/fda-critic-stripped-of-voting-rights-at-birth-control-pill-hearings/

If You Are Already aYaz Fan -   as a reviewer of this status quo with low dose birth control pills containing drospirenone, I think a reasonable question to ask yourself is “why would I take a low dose birth control pill containing an ingredient with a slightly higher risk of causing blood clots when I can take one with a lower risk that works just as well?” 

BC pills containing levonorgestrel as the synthetic form of progestin are just as effective in preventing pregnancy as those containing drospirenone. “I can see no real group of patients that this drug benefited over existing alternatives,” said Mark Woods of New York University School of Medicine. You may have been prescribed an androgen blocking, drospirenone containing birth control pill because you suffer from acne, are obese or suffer from PCOS so if you are concerned about the  increased risk of blood clots talk to your doctor about these findings in relation to your own health status to see what options you have. For simple explanations of the acne/androgen connection - just type either word into the search box on the RHS of this page.

Bayer faces more than 10,000 lawsuits over injuries *allegedly caused by the contraceptives, obviously, more long term research is required if we are to get clear evidence on this issue but at what cost and are YOU happy to be one of the guinea pigs?  If in doubt - CHECK IT OUT.PS. The Patch- Ortho Evra- which I warn about on this site doesn’t contain drospirenone but does contain higher levels of estrogen than in traditional low dose birth control pills so it could also increase the risk of blood clots. 

 Next post will be on a new brand of low dose hormonal IUD. Christmas giggle: “What do attorneys use for birth control?” Their personalities.

Thank you for visiting my site this year, peace and blessings to you and your loved ones this Christmas and see yourselves safely into the New Year.

The popular low dose birth control pills Yaz and Yasmin which contain the synthetic progestin, drospirenone, will take centre stage at the FDA’s public hearings on Dec. 8th. when the FDA’s reproductive health and drug safety committee will be looking at the safety of this  relatively ‘new’ type of progestin.

We all want to know - do low dose birth control pills containing drospirenone increase the risk of blood clots by 74% when compared to other birth control pills on the market?

I’ll post the results of the hearings  but in the meantime  this link  is worth a visit now as the first civil lawsuit launches in Canada against the manufactures of Yasmin, Bayer Inc. .The comments on the article are worth reading too but persevere to page two.

Other low dose birth control pills containing the same dosage (3 mg) of drospirenone as Yaz/Yasmin are:

• Ocella 
• Safyral
• Syeda
• Zarah
• Beyaz
• Gianvi
• Loryna

I am still awaiting the final FDA statement regarding the increased risk of blood clots with the newer low dose birth control pills. The report should be out in December but here is a little more information to hand:

Earlier analysis seems to be backed up by the latest online statements in the British Medical Journal that although there IS a higher venous thromboembolic (VTE) risk carried by the newer forms of progesterone when combined with oral contraceptives containing *30 to *40 μg ethinyl estradiol (synthetic estrogen). However, that risk still remains small, at about 10 in 10,000.The updated analysis included more than 1.2 million non-pregnant 15- to 49-year-old women in Denmark without a history of thrombotic disease.

Progestin -only pills, like the mini pill (low-dose norethisterone or desogestrel alone) or intrauterine devices which released hormones, did NOT have any impact on VTE risk compared with non-users.

Lower estrogen doses were associated with modestly lower VTE risk for oral contraceptives with norethisterone, levonorgestrel, desogestrel or gestodene but NOT with drospirenone.

With the ‘older’, low dose birth control pills (containing levonorgestrel as the type of synthetic progestin) women were still at threefold elevated risk of VTE compared with those not on any hormonal contraception, whereas those on oral contraceptives containing desogestrel, gestodene, drospirenone (Yaz) or cyproterone boosted their risk six to seven times over that of non-users .

For current users of the newer pills, Philip C. Hannaford, MD, of the University of Aberdeen, Scotland, emphasised that the risks appear real and may lead many clinicians to prescribe a combined oral contraceptive with levonorgestrel whenever possible. “It is crucial, however, not to exaggerate the risk — oral contraceptives are remarkably safe and may confer important long-term benefits in relation to cancer and mortality,” Hannaford cautioned.

I’ll follow this issue closely and post again in Dec. or when the FDA releases their latest statement about the risk level of blood clots for users of low dose birth control pills which contain drospirenone (like Yaz).

Primary source: BMJ
Lidegaard Ø, et al “Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9″ BMJ 2011; 343: d6423.

If the research into ‘enzyme type’ birth control (see yesterday’s post) replaces the hormonal method currently provided by our low dose birth control pills and other forms of hormonal contraception, we may just find memory changes associated with hormonal types of birth control can be wiped off our worry radars.

You may have read in the news recently that the contraceptive pill has an effect on the female memory. Apparently, men and women remember things differently (ah, light bulb moment, as those of you who have ever argued with a man will agree!) If the research into ‘enzyme type’ birth control (see yesterday’s post) replaces the hormonal method currently provided by our low dose birth control pills and other forms of hormonal contraception, we may just find memory changes associated with hormonal types of birth control can be wiped off our worry radars.

You may have read in the news recently that the contraceptive pill has an effect on the female memory. Apparently, men and women remember things differently (ah, light bulb moment, as those of you who have ever argued with a man will agree!) Don’t think you’re going to lose your memory or fall headlong into early dementia if you keep popping your low dose birth control pills. Researchers have found that women who use on today’s low dose birth control methods have memory changes which cause them to recall similarly to the way men do.

The low dose birth control pill changes the TYPE of information women recall

Men use their right brain for memory and to remember the ‘big picture’ rather than the details of a scene/event whereas women usually remember the details surrounding an event by using their left brain. That is- if you are NOT on a type of low dose birth control. If you take a form of low dose birth control, even for a s little as a month or two, it has been found that the synthetic hormones they contain affect a woman’s memory to produce results like a man does- i.e remembering the ‘big picture’.

WHY does this happen?  Research has found a link between a woman’s sex hormones and her ‘left brain’ memory.

Synthetic estrogen and progesterone in forms of low dose birth control suppress sex hormones in a woman’s body which is why some women complain of loss of libido. Studies show that a woman’s natural estrogen and progesterone production are linked to her left brain memory so by suppressing these with the use of synthetic hormones, the function of memory is also affected.

What is the implication of this? – well, I’ll leave you to figure that one out but if you are on low dose birth control ladies and your guy has heard about this, your ‘defense memory’may no longer be the big gun the next time you want to win a point!

Source:UC Irvine research- Shawn Nielsen, Nicole Ertman and Larry Cahill

No More Daily Pill Popping?

The next step in developing better birth control for women looks set to use enzymes instead of synthetic hormones to prevent ovulation. If this is successful, the benefits could mean an end to flooding a woman’s body with chemicals(Yeay!) and the removal of one of the major risks associated with current birth control Pills - cardiovascular disease.

If this new type of birth control becomes a reality, we don’t yet know what form the ‘enzyme’ treatment will take but missed pill dramas and other associated ‘Pill’ annoyances could become ancient tales from history.

Rhesus Macaque monkeys are being studied by Jon Hennebold and a team of researchers at Oregon’s Health & Science University (in the Oregon National Primate Research Center) because their reproductive systems are very similar to those of humans. The research team has discovered which enzymes in these monkeys can be targetted to prevent the release of an egg from an ovary so you can imagine the excitement about the application for us females!

While it is early days yet, it is to be hoped that funding will support ongoing research into any method of birth control that increases effectiveness, reduces side effects and relieves women of the daily burden to pop that pill. Not wishing to burst the balloon before it’s inflated, I can’t help but wonder what the effects of ‘fiddling’ with our endocrine system as opposed to interfering with our hormones will mean for our bodies (AND our emotions!) I just hope that it’s as minimal as possible and that WHEN/IF this research does bring us a new generation of birth control, that our concerns will be safely and satisfactorily alleviated and our mood swings will be left up to us!

I’ll keep you up to date as more information on this new generation of birth control becomes available. Tomorrow I’ll put up a brief comment about the latest ‘findings’ about the low dose birth control pill and your memory…

Have you got your copy of my handy little ‘vagina’ guide yet?  Christmas present for Mum? Excellent value at $11.95 and it never goes out of  ‘fashion’!

One Giant Step for Mankind? You were there when it happened.

Margaret Sanger would be dancing in the streets if she had lived to see the giant leap forward in women’s health that has been made this week in the US. Sanger founded the American Birth Control League which became, in 1942, the Planned Parenthood Federation of America. This week Planned Parenthood is celebrating Monday’s ruling by the Department of Health and Human Services (HHS) that birth control is now classed as a basic preventative health care service that should NOT attract a co-payment. For a wider perspective, read this great article by the vice president of Planned Parenthood.

Free Birth Control for Women no doubt has the insurers scowling rather than dancing as the IOM (Inst. of Medicine) has recommended to the government that the service also includes:

Cost Benefits of Free Birth ControlWith almost 50% of US pregnancies unintended, if you’re thinking that this is going to cost the government heaps check these IOM figures out:

 If you or a friend has bought this emergency birth control pill called EVITAL- please read the information HERE and talk to your doctor before continuing with this medication as  it has not been approved by the FDA .The link contains a picture of the pack for this medication.

The EVITAL pack may be a counterfeit version of the “morning after pill” and may not be safe or effective in preventing pregnancy.

With a flash of his magic wand your male partner could soon banish the fall out from low dose birth control pills for ever!

Mood swings, irritability, weight gain et al may soon be the archived side effects for women if your male partner is the sensitive, macho type who could handle 15 mins. of scrotum exposure, a teeny weeny invasion of his private parts and a band aid down below. Of course, the issue of ‘trusting men with the responsibility for birth control’ is a whole different ball game (sorry!) and not for today’s post but it’s good to know the latest ‘foreplay’ on this controversial subject.

RISUG (”Reversible Inhibition of Sperm Under Guidance”) is getting close to being made available to men outside India where it has been trialled for 15 years. The RISUG injection method into a man’s vas deferens (sperm tube) was invented by Prof. Sujoy K. Guha but the Male Contraception Information Project has purchased rights to begin studying RISUG in the U.S. and developing it for the rest of the world. 2015 may see RISUG marketed to US men as a far less invasive option to vasectomy. Issues with the syringe design slowed down the project somewhat but in May 2011 these were resolved. A potential manufacturer has been selected and clinical trials beginning in 2012 will develop the ‘VASALGEL ‘ birth control method for men. Funding for the $5million project however, needs to be kept up - MCIP are encouraging people to sign a petition to encourage large funders to financially back the project through to the end.

VASALGEL/RISUG procedure : imagine making a teeny, weeny hole in a Lilliputian’s bean bag through which is pulled a little loop of ‘spaghetti’. Into that little thread of spaghetti 60mg of polymer gel is injected, the loop is then released whereupon it snaps back inside the weeny bean bag before a little band aid is applied over the almost invisible hole. There you have it -VASALGEL or  from our viewpoint- “low dose birth control side effects begone!”

For additional excellent and fascinating, detailed information on the current stages of play with RISUG development GO HERE. The petition form is also there if you wish to sign it and for the bravehearts amongst you can even watch a video of the procedure.

Effectiveness of Vasalgel The gel doesn’t need to block the sperm tube (vas deferens) fully because the active ingredient it contains kills the merry swimmers as they pass by. A minimum of 7 years of contraception is achieved for guys after only 15 mins. in the hands of a skilled doctor - the procedure is reversible at any time with no discovered ill effects or damage to future sperm. There is only a 10 day ‘condom backup’ period after the procedure as compared with up to 3 months for a vasectomy. With vasectomy some men report prostate issues but to date no similar reports have been logged with RISUG. The fact that the gel does not completely block the sperm tube works in its favour since no ruptures or ‘backup’ of sperm occurs.

WomenCare Global- Once Vasalgel has been proved to be safe and effective, it is hoped that the project will be turned over to a nonprofit organisation called WomenCare Global which specialises in supporting the completion of reproductive health products and then getting them onto the market.　

My last statement on my previous post was “I am not aware of any proven, reliable herbal form of birth control“- this was true for women’s birth control but when it comes to male birth control in Indonesia it is a different bunch of leaves.

Male birth control pill available next year in Indonesia? Not so far away from my desk here in Oz, a 6ft tall leafy shrub called Gandarusa is growing in a forest on the eastern coast of Java. Gandarusa, used by the Indonesians as an herbal remedy for stress, has been found to also reduce fertility in men. Testing Gandarusa specifically for use in male birth control has been carried out at Airlangga University since 1987. With a 100% success rate to date, trials on 350 couples are expected to be completed by the end of this year which means 2012 could be the year that the ‘long laboured’ male birth control pill will be ‘born’, in Indonesia anyway.

How does Gandarusa work?

It changes the chemistry of the enzyme on tip of each sperm making them unable to pierce the outer wall of the egg- if the enzyme is inactive or reduces the activity, the egg cannot be fertilized.Don’t get too excited about Gandalusa being available in the states yet though. The FDA’s strict testing process could take years. The risk will be yours remember if you fancy a quick holiday in Indonesia to shop for Christmas stocking fillers!

Are there any side effects? - as I understand it, the good news for the guys is:

• few side effects, if any, reported
• no diminished libido reported – in fact quite the opposite with one guy!
• no altering of male hormones – wouldn’t ya know it?
• contraceptive effect is not permanent - fertility is reversed within 2 months after stopping the daily pill

The fact that this method is not permanent and possibly will not harm the body, should meet with the approval of the Islamic leaders but the age old question still remains-

Will men use it?  In Indonesia (?) most men think contraception is a woman’s responsibility (currently only condoms and vasectomy are used) fewer than 2% of men participate in birth control. Even if the male birth control was to be available to the world tomorrow, it still begs the question - how do we ‘sell’ a male birth control pill?

I’ll post a free copy of my book ‘Happy Vaginas for the Over 40s’ to the person who sends in the funniest ‘ad script’ for the male birth control pill to this post by Christmas!

While guys and their ‘contraception careers’ are the flavour of the posts this week, I’ll bring you up to date on the current RISUG state of play in my next post.

Several brands of low dose birth control pills are reviewed on this site, including Yaz and Yasmin, which along with Beyaz/Safyral are currently in the news because of a fear that a particular hormone they contain, drospirenone, increases the risk of blood clots. I am waiting for the outcome of the latest study by the FDA on 800,000 women as to the effects of drospirenone on blood clotting and will adjust or remove the Yaz information accordingly. The results of the study are due later this Summer, in the meantime I encourage those of you who are ‘happy’ with this low dose birth control pill to watch out for possible symptoms of blood clots such as chest pain or leg pain or talk to your doctor about using an alternative form of low dose birth control.

Estrogen in low dose birth control pills is the ingredient that is thought to make blood more likely to clot. As drospirenone is a type of progestin, not a type of estrogen, and in Yaz 3mg of it are combined with 30mcg of ethinyl estradiol (estrogen), it will be interesting to see what the study reveals about this cocktail- I’ll leave you to make the leap I did.

Yaz has its followers due its success in reducing the common side effects of other low dose birth control pills and in reducing acne. However, the manufacturer Bayer, is reputed to be facing several thousands of lawsuits. Lawsiuts are brought for a wide range of reasons (some marketing, some medical) so don’t jump to wild conclusions here, get as much information about the details as you can.

What increases the risk of blood clots forming? It is the estrogen in low dose birth control pills and other forms of hormonal contraception containing estrogen (also HRT) that is thought to make blood more likely to clot, this is called hypercoagulability. Estrogen itself doesn’t form a blood clot.

Progesterone/Progestin only forms of birth control such as the ‘mini pill’, Depo Provera shot, Implanon and Mirena are ’safer’ to use from this aspect and would certainly be a better choice for women over 35, who smoke, who are overweight or who are breast feeding. Reminders for the mini pill -

• progestin only pills MUST be taken at the same time every day to give maximum protection
• for the first month of usage, a condom must also be used, as with other BC pills
• even being 3 hrs late in taking your mini pill means you should use a condom for the rest of that cycle (not 48hrs only )
• while you may take 2 mini -pills in one day, you can’t take 2 mini - pills the next day to make up for the missed one as you can with a combined birth contol pill

Combined low dose birth control pills prevent most women from ovulating whereas progestin only birth control types act mainly to thicken cervical mucus and change the uterus lining to prevent pregnancy- about 50% of women also stop ovulating on progestin only contraception.

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